The Korean Ministry of Food and Drug Safety (MFDS) has introduced a new initiative focused on three aspects: organoid alternatives to animal testing, legal framework for CDMOs, and the acceleration of GMP inspections. First, the Bio Future Development Council will establish regulations on organoids, which are advanced biological models that will decrease dependence on animal testing. The MFDS plans to work with developers in Korea to develop a review system that is consistent with global trends, such as those set by the US FDA. Second, the MFDS is drafting regulations to recognize and give a legal framework to contract development and manufacturing organizations (CDMOs). This will include establishing GMP certification systems for raw materials and promoting localization of critical inputs such as culture media, cellular materials, and raw materials. Third, the ministry will tackle approval delays by simplifying GMP due diligence and hopes to reduce the review timeline to under six months.
The Vietnam Ministry of Health (MOH) has made public a draft revision of its 2007 organ and tissue donation policy and is now seeking public comments. This is the first time that comprehensive provisions on stem cells have been made. The bill proposes to regulate stem cell donation, storage, and use in response to increasing ethical and legal issues. Major provisions outline the licensing of stem cell facilities, regulations for private stem cell banks, and the right of stem cell donors to be recognized. Foreign cooperation in stem cell therapy and research is permitted, subject to the condition that facilities are up to government standards. Embryo creation for stem cell research or treatment is specifically barred. The consultation process will run until late May 2025. The amendment, if passed, will drastically change the legal landscape of stem cell research in Vietnam.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.